HyperView

GUDID 00869661000244

HyperView Verification Card Set

Hypermed Imaging, Inc.

Patient monitoring system module, pulse oximetry

• Primary Device ID: 00869661000244
• NIH Device Record Key: a13716ea-2a24-4379-9cac-d2d57dd7ab3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperView
• Version Model Number: 105-A005
• Company DUNS: 034813512
• Company Name: Hypermed Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869661000244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161237

FDA Product Code

• MUD: Oximeter, Tissue Saturation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-23

On-Brand Devices [HyperView]

• 00869661000251: HyperView Accessories Kit
• 00869661000244: HyperView Verification Card Set
• 00869661000237: HyperView Power Cord and USB Set
• 00869661000220: HyperView Calibration Verification System
• 00869661000213: HyperView Docking Station
• 00869661000206: HyperView Camera